Author of

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  P2.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 225)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 14662

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    P2.08-001 - A Randomized, Placebo-Controlled Study of Amatuximab in Combination with Pemetrexed and Cisplatin (P/C) in Subjects with Pleural Mesothelioma (ID 829)

    09:30 - 09:30  |  Author(s): K. Hoffman
    • Abstract
    • Slides

    Background:
    Amatuximab is a chimeric monoclonal antibody that binds to mesothelin, which is highly expressed in malignant mesothelioma and largely absent from normal tissue. In vitro studies indicate that amatuximab potentially has anti-tumor activity via antibody-dependent cellular cytotoxicity. Amatuximab was studied in a Phase 2 malignant pleural mesothelioma (MPM) trial which demonstrated that the safety profile of amatuximab in combination with P/C was consistent with that seen previously for the P/C regimen. Although PFS was not significantly different from historical results of P/C alone, the median OS was 14.8 months (as compared to 13.3 months for P/C). The post-hoc PK/PD analysis demonstrated that amatuximab trough concentrations were a significant predictor of both OS and PFS where higher concentrations were associated with longer OS (583 days; p=0.0202 ) and PFS (238 days; p<0.001).
    
    Methods:
    560 subjects with previously untreated, unresectable malignant pleural mesothelioma (MPM) will receive P/C and are randomized 1:1 to receive weekly amatuximab, 5 mg/kg or saline placebo IV in this global study. The primary endpoint of the study is to demonstrate whether amatuximab in combination with P/C has superior OS compared with P/C in subjects with MPM. The secondary endpoints are to compare amatuximab versus placebo with regard to PFS, ORR, duration of response, health-related QOL (LCSS-Meso), and the safety of amatuximab when administered with P/C. Clinical trial information: NCT02357147.
    
    Results:
    Not applicable
    
    Conclusion:
    Not applicable
    
    

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